Johnson Matthey Sr Document Control Coordinator in US - Devens, Massachusetts
Sr Document Control Coordinator
LocationUS - Devens, MA
Johnson Matthey (‘JM’) is a global leader in science that enables a cleaner and healthier world. With over 200 years of sustained commitment to innovation and technological breakthroughs, we improve the function, performance and safety of our customers’ products. Our science has a global impact in areas such as low emission transport, pharmaceuticals, chemical processing and making the most efficient use of the planet’s natural resources. Today more than 14,000 Johnson Matthey professionals collaborate with our network of customers and partners to make a real difference to the world around us.
Participate in complex documentation/Quality Assurance activities, which include document change control, document issuance and record retention. Familiar with GMP regulations. Strong working knowledge of quality systems.
Maintain and make recommendations on improvements to quality documentation systems, which includes records control and records retention procedures.
Issue and ensure control of production batch records, standard operating procedures (SOPs), Work Instructions, Test methods, and controlled forms.
Perform and make recommendations to processes/procedures for controlled changes to written procedures, including ensuring the implementation of revision control procedures, numbering, and storage systems for documentation.
Resolve discrepancies and ensure that operating and change control procedures are brought into compliance with GMPs.
Ensure that the documentation databases and directories are updated and maintained.
Interact with personnel to ensure GMP documentation compliance.
Determine QA documentation SOPs and manage and/or conduct training sessions for QA documentation SOPs.
Participate in internal audits, client audits, and inspections from regulatory agencies by providing documentation support.
Maintains companywide training files.
Participate in the tracking of quality system items in Trackwise, including revision of applicable SOPs and company training.
Maintenance of a Document management system and Training management system.
Are you the ideal candidate?
Bachelor’s degree or equivalent
Preferably 4+ years’ experience in QA/Document Control, or 5-7 years progressive experience in multi-function administration in a GMP environment
Understands moderately complex principles and concepts in area of work responsibility
Familiarity with regulations, such as GMP, Q7A, etc.
Extensive experience with databases, (MS Access, Excel, etc.)
Experience with Master Control and Trackwise
Johnson Matthey is an Equal Opportunity Employer. Johnson Matthey does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, genetic information, citizenship, veteran status, or other characteristic protected by law.
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